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FDA 510(k)

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS

K-Number: K844586 · 1984-12-11

ApplicantInstrumentation Laboratory CO
Decision Date1984-12-11
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K844586. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS?

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K844586.

When did IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS receive FDA 510(k) clearance?

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844586.

Who is the listed applicant for IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS?

The FDA product code for IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS is JJF.

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Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: JJF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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